Archive: Company News
Company News: Curetis Appoints Christopher M. Bernard as Chief Executive Officer of Newly-Formed U.S. Subsidiary
– Former Chief Commercial Officer of Epic Sciences brings valuable experience in sales, marketing and commercialization of in-vitro diagnostic platforms
Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic solutions, today announced that Christopher M. Bernard has been appointed to the newly-created role of President and Chief Executive Officer of the Company’s North American subsidiary Curetis USA, Inc., effective immediately. He will be responsible for the development of the new subsidiary based in San Diego, CA, and will lead the marketing and sales initiatives for Curetis in the U.S.
Curetis USA, Inc. was founded to drive the future development and sales of the Company’s Unyvero Platform in North America. The Company recently announced completion of enrollment in the U.S. FDA trial of Unyvero for the detection of lower respiratory tract infections. Curetis plans to submit the Unyvero LRT55 Cartridge for FDA clearance by the end of 2016, with potential clearance and commercial launch targeted for the first half of 2017.
“We are pleased to have Chris join Curetis as the CEO of our U.S. subsidiary,” commented Oliver Schacht, PhD, CEO of Curetis N.V. “He is a highly accomplished executive with proven ability to develop successful sales and marketing strategies, drive growth for emerging companies, manage operations and deliver on key strategic, commercial and operational objectives. He is an important addition to the leadership team at Curetis and will play a critical role in enhancing the Company’s growing global presence by establishing and leading its U.S. subsidiary, based in San Diego.”
Mr. Bernard joins Curetis with more than 22 years of diagnostics, biopharmaceutical and translational research industry experience, including roles in executive management, strategic development, product commercialization, marketing and sales. Prior to joining Curetis, Mr. Bernard served as Chief Commercial Officer of Epic Sciences, developer of one of the few commercially available platforms that can identify circulating tumor cells in the blood. In this role, Mr. Bernard was responsible for the expansion of Epic’s technology in collaboration with pharmaceutical and biotech companies and leading cancer research centers and the commercialization of Epic’s independent and companion diagnostic products.
Prior to joining Epic Sciences, Mr. Bernard worked at Metabolon, Inc. as an Officer and Senior Vice President, Sales and Marketing, where he rebuilt the company’s Metabolytics business, a business-to-business biochemical profiling service responsible for the company’s total sales at the time. Prior to Metabolon, he served as Vice President, Sales and Marketing and as an Officer of Abaxis, Inc., directing the sales and marketing efforts for the company’s point-of-care diagnostic chemistry platform, Piccolo Xpress®. Mr. Bernard began his career at Cytyc Corporation (Hologic, Inc.), ultimately becoming the regional business director where he was responsible for growth in sales and management of a portfolio of diagnostic products, including ThinPrep® Pap Test and Imager, and NovaSure® endometrial ablation.
Mr. Bernard received a B.A. in Psychobiology from Hiram College, Ohio, where he is a current board member of the Center for Entrepreneurship.
“Curetis is a cutting-edge molecular diagnostics company with tremendous opportunity,” said Mr. Bernard. “I am very excited by this opportunity to lead Curetis USA and support the planned North American commercialization of the Unyvero platform. I look forward to working with Curetis’ outstanding executive team and board to advance the company and position it for further success.”
He added: “This is an exciting as well as strategically important time to be joining Curetis. Once FDA clearance is accomplished, the Unyvero System will make an immediate impact in U.S. hospitals in two key areas: lower respiratory tract infections and antibiotic resistance. In the U.S., there is a death every 10 minutes due to pneumonia, and respiratory infections are the second leading cause of hospitalizations. Coupled with increasing global concern around super bugs that are resistant to standard antibiotics, this makes the timing of a U.S. launch for Curetis ideal.”
Company News: Curetis Announces Participation in Clinical, Scientific and Investor Meetings in the Third Quarter 2016
Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic solutions, today announced its participation in major scientific and investor meetings in the third quarter of 2016.
July-August:
AACC Annual Meeting & Clinical Lab Expo 2016, July 31 – August 04, 2016, in Philadelphia, PA, USA. Exhibition booth no. 135.
September:
35th Annual Meeting of the European Bone & Joint Infections Society, September 1-3, 2016, in Oxford, UK. Exhibition booth no. E05. Joint meeting with Curetis´ partner Heraeus Medical.
68th Annual Meeting of the German Society for Hygiene and Microbiology (DGHM), September 11-14, 2016, in Ulm, Germany. Exhibition booth details to be confirmed. In addition, Curetis will host a Lunch Symposium.
Rodman & Renshaw 18th Annual Healthcare Conference 2016 New York, September 11-13, 2016, in New York, NY, USA. Company Presentation and One-on-One Meetings.
Company News: Curetis Completes Sample Enrollment in Unyvero U.S. FDA Trial in Lower Respiratory Tract Infections
– Last patient enrolled in prospective arm of IVD trial
– More than 2,250 prospective and retrospective samples enrolled in study
– Data to be complemented with up to 500 additional contrived samples with focus on rare pathogens
Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic solutions, today announced the completion of patient enrollment in its Unyvero U.S. FDA trial. The primary endpoint of the prospective and retrospective study is the performance of the Unyvero LRT55 Lower Respiratory Tract cartridge in detecting lower respiratory tract infections as compared to microbiology culture, the current diagnostic standard of care.
In less than a year, a total of 2,254 tracheal aspirate and bronchoalveolar lavage samples have enrolled at nine participating sites across the US, including Mayo Clinic, Northwestern University, Johns Hopkins Hospital, UCLA and Columbia University Medical Center. 1,698 samples were prospectively tested, and 556 were retrospectively tested with the LRT55 Unyvero Lower Respiratory Tract Cartridge as well as using standard of care microbiology culture. The Principal Investigator of the trial is Dr. Robin Patel, Director of the Clinical Bacteriology Laboratory and Infectious Diseases Research Laboratory, and Chair of the Division of Clinical Microbiology at Mayo Clinic.
“Our Clinical Trial Operations team would like to thank all of the participating sites, as well as our Principal Investigator Robin Patel, for their dedicated support during the study,” said Johannes Bacher, Chief Operating Officer of Curetis. “We are proud to conclude patient enrollment this month as planned, after running more than 5,650 Unyvero LRT55 Cartridges in a study with complex sample management logistics.”
“We are very pleased to have finished enrolment of our U.S. study on schedule and according to plan,” said Dr. Oliver Schacht, CEO of Curetis. “In preparing for our IPO during the second half of last year, we outlined a number of anticipated near- and mid-term milestones for the Company. Following the commercial launch of our blood culture (BCU) application cartridge earlier this year, the completion of enrollment in our U.S. trial represents another important accomplishment from that list. I am proud of what our teams have accomplished since becoming a public company, and we look forward to the release of initial top-line data from the study later this year.”
After completion of all molecular comparator testing, data will be unblinded and Unyvero results will be compared against an independent molecular composite comparator based on pathogen DNA analysis by PCR and sequencing. Completion of the analysis is expected in the second half of 2016. Subsequently, a statistical analysis based on more than 350,000 data points combined from microbiology, Unyvero runs, additional molecular testing and bidirectional sequencing will be prepared. FDA submission is anticipated before the end of the year, with a goal of securing FDA clearance for Unyvero and commercialization of the technology in the first half of 2017.
In order to provide additional data points for certain rare pathogens, e.g. Legionella, Mycoplasma, Pneumocystis, up to 500 contrived samples from well characterized pathogen strains from several international strain providers will be spiked into negative matrix and tested with Unyvero at several clinical trial sites. It is expected that this phase will add approximately 1,500 cartridge runs, as double testing will be performed on two systems in parallel for software validation, including daily controls and a number of sample repeats.
LRT55 is a second-generation cartridge based on the design of the CE-IVD marked P55 cartridge marketed outside the U.S. It features 40 markers, a novel control concept and provides the most comprehensive molecular marker panel for lower respiratory tract infections available today.
Further details about the Unyvero platform are available at the Unyvero product website – www.unyvero.com.
Company News: Curetis Reports Results of the Annual Shareholder Meeting Held on June 16, 2016
– Dr. Prabhavathi Fernandes elected as member of the Supervisory Board
Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis”), a developer of next-level molecular diagnostic solutions, today reported the results of its Annual Shareholder Meeting (“AGM”) held in Amsterdam on June 16, 2016.
The shareholders approved all items on the agenda of the AGM, including the election of Dr. Prabhavathi Fernandes (CEO of Cempra Pharmaceuticals, Inc., Chapel Hill, NC, USA) as a member of Curetis´ Supervisory Board for a three-year term until 2019. Prabhavathi Fernandes has profound knowledge in infectious diseases and antibiotics as well as experience in successfully founding, building up and leading several biotech companies and taking one public on Nasdaq raising more than half a billion dollars.
Moreover, Dr. Holger Reithinger and Dr. Rudy Dekeyser were re-elected for another one-year term, respectively. In addition, the proposed resignation of Dr. Frank Mühlenbeck, the creation of a new Stock Option Program for the Company and associated changes to the Supervisory Board remuneration policy as well as changes to the Management Board’s Remuneration Policy and Stock Option grants were also approved by the shareholders.
“We are excited about the election of Prabha Fernandes to our board,” said Oliver Schacht, CEO of Curetis. “She brings unparalleled MDx industry expertise and will play a crucial role in helping Curetis prepare for the planned market launch in the US. Moreover, we are pleased that all proposed AGM resolutions have been approved by our shareholders.”